What the label lists and what reports show
Nystatin side effects
Nystatin's FDA label lists its adverse reactions in its own words. FAERS holds 27,281 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (2,061 reports).
- Generic listed
Check it at the source: the nystatin FDA label on DailyMed (effective May 1, 2026, Torrent Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General. )
Source: FDA drug label, Torrent Pharmaceuticals Limited, effective May 1, 2026 (SPL set 559b5bd4-3564-4437-8d0a-fa3a972f8b83), via openFDA; the full label on DailyMed
What do FAERS reports show?
27,281 reports list nystatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,744 are coded as a death and 12,172 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nystatin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions